UnityPhilly Response App for Overdose Reversal

ConditionOpioid Overdose

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorDrexel University

About this trial

The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app. The main hypotheses to answer are:

Hypothesis 1: UnityPhilly signal rates relative to EMS calls will increase over time. The primary outcome will be assessed as the total number of overdoses signaled by participants relative to all overdose-related EMS calls, per year.

Hypothesis 2: The number of cases where a nearby UnityPhilly participant successfully reverses an overdose with naloxone will increase over time. The primary outcome will be assessed as the number of successful reversals relative to the total number of responder arrivals, per year.

Participants will be supplied with the UnityPhilly app, training on how to use the app and respond to an opioid overdose using naloxone, and respond to follow up surveys about their experiences.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

owning a smartphone with a data package;

living or working in one of three identified Philadelphia neighborhoods;

aged 18 or older.

Disqualifiers

persons aged under 18 years of age

Trial population

Key study enrollment criteria will include: owning a smartphone with a data package; living or working in one of three identified Philadelphia neighborhoods, i.e., Kensington, South Philadelphia, West Philadelphia; aged 18 or older. Furthermore, participants will be placed into one of the five subgroups based upon 30-day self-report of non-medical opioid use, medical opioid use, abstinence or recovery from any opioid use, family member or community self-affiliation (see subgroups 1-5 above). The study will enroll 450 participants and all will be assigned the intervention, i.e., UnityPhilly app.

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

UnityPhilly app
Other intervention
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.

Treatment groups

450 Participants

are divided into 5 treatment groups

Group A: Active non-medical opioid user1 intervention

Group B: Active prescription medical opioid user1 intervention

Group C: Person in recovery from opioid misuse1 intervention

Group D: Caregiver/family members of groups 1, 2, 31 intervention

Group E: Concerned community member1 intervention

Trial outcomes

Primary outcomes

Rate of Overdoses Signaled

\# events signaled by participants vs. # all overdose-related EMS calls, per year

Time frame

2 year period

Rate of Overdoses Reversed

\# successful opioid reversals vs. # all arrivals, per year

Time frame

2 year period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Drexel University

Lead sponsor

University of Michigan

Collaborator

Source ClinicalTrials.gov

Apply now